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1、 FOOD SAFETY AUTHORITY OF IRELAND Assessment of the safety of“probiotics”in food supplements Report of the Scientific Committee of the Food Safety Authority of Ireland 2024 FOOD SAFETY AUTHORITY OF IRELAND Report of the Scientific Committee of the Food Safety Authority of Ireland Assessment of the s

2、afety of“probiotics”in food supplements Published by:Food Safety Authority of Ireland The Exchange,Georges Dock,IFSC,Dublin 1,D01 P2V6 T+353 1 817 1300 E infofsai.ie www.fsai.ie FSAI 2024 Applications for reproduction should be made to the FSAI Communications Unit ISBN:978-1-910348-76-5 Report of th

3、e Scientific Committee of the Food Safety Authority of Ireland Assessment of the safety of“probiotics”in food supplements FOOD SAFETY AUTHORITY OF IRELAND Page 1 Content List of Figures.3 List of Tables.3 GLOSSARY.4 EXECUTIVE SUMMARY.7 PURPOSE OF THE REPORT.11 1.BACKGROUND.12 1.1 REGULATION OF FOOD

4、SUPPLEMENTS CONTAINING“PROBIOTICS”IN THE EU.12 1.2 EFSA:QUALIFIED PRESUMPTION OF SAFETY(QPS).13 1.3 COMPARISON BETWEEN QPS AND GENERALLY RECOGNIZED AS SAFE(GRAS).16 1.4 APPROACHES TO ASSESSING THE SAFETY OF“PROBIOTICS”.17 1.5“PROBIOTICS”IN COMMERCIALLY AVAILABLE FOOD SUPPLEMENTS.19 1.5.1 Lactobacill

5、i.19 1.5.2 Bifidobacteria.20 1.5.3 Bacillus.21 1.5.4 Enterococci.21 1.5.5 Saccharomyces.23 1.6 REPORTED ADVERSE EVENTS ASSOCIATED WITH THE CONSUMPTION OF“PROBIOTICS”23 2.QUESTIONS TO THE SCIENTIFIC COMMITTEE.26 QUESTION 1:WHAT IS THE COMMITTEES VIEW ON THE MOST APPROPRIATE SAFETY CRITERIA TO USE WHE

6、N ASSESSING THE SAFETY OF“PROBIOTICS”IN FOOD SUPPLEMENTS?.26 2.1 Microorganism characteristics.26 2.2 Safe production and incorporation of“probiotics”in food supplements.30 QUESTION 2:WHAT EVIDENCE SHOULD A FOOD SUPPLEMENT PRODUCER USE TO DEMONSTRATE THE SAFETY OF“PROBIOTICS”WHEN PRODUCING A FOOD SU